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Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

5 maggio 2020 aggiornato da: Johns Hopkins University

A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

This pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying mechanisms of benefit.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. Investigators also hypothesize consumption of the Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • Johns Hopkins University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
  • Other causes of bowel symptoms excluded to the satisfaction of the Study Team
  • Age at least 18 years at initial screening visit
  • Patients who are able to sign and understand the study's informed consent form
  • Patients able to complete all screening evaluations and procedures

Exclusion Criteria:

  • Patients in inpatient hospital care
  • Severe or refractory bowel or psychological symptoms
  • Current consumption of a Paleolithic diet
  • Known Celiac disease
  • Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
  • Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
  • Patients unable to speak English
  • Inability to obtain informed consent
  • Pregnant or nursing women
  • Any condition, which in the opinion of the investigator, would interfere with study requirements

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Paleolithic Diet
Altro: Paleolithic diet
Paleolithic diet
Comparatore attivo: General Healthful Diet
Altro: General Healthful Diet
General Healthful Diet

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Vitality
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Vitality as measured on the vitality subscale of the short form health survey (SF36). This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys. The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The lower the score the more disability. The higher the score the less disability.
The change between baseline and 4 weeks (post-intervention).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).

Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.

GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Depression
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).

Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire.

PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Activity level
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise. It is designed to be reliable valid and easy to complete quickly without a need for detailed review. Lower scores indicate less activity and higher scores equal more activity.
The change between baseline and 4 weeks (post-intervention).
Gastrointestinal symptoms
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).

Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale

a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity as measured by the Visceral Sensitivity Index. Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Overall health status (Short Health Scale)
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Overall health status as measured by the Short Health Scale questionnaires. The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Overall health status (EQ-5D)
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Intestinal permeability
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Change in intestinal permeability as measured by plasma zonulin levels
The change between baseline and 4 weeks (post-intervention).
Change in inflammatory markers
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Change in inflammatory markers as measured by serum C-reactive protein levels
The change between baseline and 4 weeks (post-intervention).
Change in stool metabolomics
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Change in stool metabolomics as measured by stool metabolite testing.
The change between baseline and 4 weeks (post-intervention).
Change in stool microbiome profile
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of urine.
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool.
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of saliva.
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of blood.
Lasso di tempo: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Johns Hopkins University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 aprile 2018

Completamento primario (Effettivo)

1 aprile 2020

Completamento dello studio (Effettivo)

1 aprile 2020

Date di iscrizione allo studio

Primo inviato

18 gennaio 2017

Primo inviato che soddisfa i criteri di controllo qualità

25 gennaio 2017

Primo Inserito (Stima)

30 gennaio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00082222

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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